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The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 compared to placebo and Formoterol Fumarate (Foradil Aerolizer) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Inhaled PT005 2.4 mcg |
|
| 2 | Experimental | Inhaled PT005 4.8 mcg |
|
| 3 | Experimental | Inhaled PT005 9.6 mcg |
|
| 4 | Placebo Comparator | Inhaled Placebo |
|
| 5 | Active Comparator | Formoterol Fumarate 12 mcg (Foradil Aerolizer) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled PT005 | Drug | single dose, inhaled |
| |
| Inhaled PT005 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline across the three doses of inhaled PT005 compared with placebo. | Serial FEV1 measured over 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of action (>10% improvement in FEV1 from baseline) | Serial FEV1 measured over 12 hours | |
| Peak FEV1 | Serial FEV1 measured over 12 hours | |
| Trough FEV1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colin Reisner, M.D. | Pearl Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woolcock Institute of Medical Research | Glebe | New South Wales | 2037 | Australia | ||
| Australian Clinical Research Organisation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25060541 | Derived | Quinn D, Seale JP, Reisner C, Fischer T, Golden M, Fernandez C, Darken P, St Rose E, Thomas M, Tardie G, Orevillo C. A randomized study of formoterol fumarate in a porous particle metered-dose inhaler in patients with moderate-to-severe COPD. Respir Med. 2014 Sep;108(9):1327-35. doi: 10.1016/j.rmed.2014.06.009. Epub 2014 Jul 3. |
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| Drug |
single dose, inhaled |
|
| Inhaled PT005 | Drug | single dose, inhaled |
|
| Inhaled placebo | Drug | single dose, inhaled |
|
| Formoterol Fumarate 12 mcg (Foradil Aerolizer) | Drug | single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer |
|
|
| Serial FEV1 measured over 12 hours |
| Peak inspiratory capacity (IC) | Serial IC measured over 12 hours |
| Peak expiratory flow rate (PEFR) | Serial PEFR measured over 12 hours |
| Forced vital capacity (FVC) | Serial FVC measured over 12 hours |
| Auchenflower |
| Queensland |
| 4066 |
| Australia |
| Mater Hospital | South Brisbane | Queensland | 4101 | Australia |
| Primorus Clinical Trials | Christchurch | 8014 | New Zealand |
| P3 Research | Wellington | 6035 | New Zealand |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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